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Director, Clinical Development
Posted on Feb 15
My client is in start-up mode seeks a Director to oversee clinical research and drug safety activities along with clinical research strategy. The ideal candidate will take on the following tasks:
Oversee clinical study activities.
Recruit, manage and develop a small clinical research and drug safety team.
Oversee data analysis, evaluation and reporting of clinical data including study reports, FDA and ethics committee progress/final reports, and assist with manuscript preparation.
Forecast clinical activities and assist in developing clinical operational budget.
Assist in oversight of clinical site management especially in regards to recruitment, monitoring, compliance and maintaining excellent partnerships with site PIs and staff to maximize subject enrollment.
Provide safety surveillance for all clinical trial products for development of product safety profiles and informed consents, investigator brochures, protocols and clinical safety reports.
Coordinate safety surveillance procedures to ensure corporate compliance with national and international adverse event reporting requirements.
Assures compliance with applicable regulations and standard operating procedures for the reporting of adverse events to regulatory agencies.
Oversee the preparation of NDA Safety Updates, IND safety reports, investigator communications, Product Labeling/Package Inserts, Risk Management Plans and other reports as necessary.
MD/DO degree and Ophthalmology experience.
License to practice medicine -- US or equivalent
5+ years of industry experience with knowledge of GCP, clinical trial conduct data interpretation and safety in clinical development.
Strong organizational and communication skills are required as well as in-depth knowledge of clinical research, including FDA and international regulations, GCPs, clinical study design and documentation, conduct of clinical trials and pharmacovigilance.
Program management skills enabling efficient planning and execution of program milestones within budget and in time.
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